BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    6 Output Oncobionic Generator

    Reg #: 9611854 · FEI: 3002807258 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IGEA SPA
    Registration Number
    9611854
    FEI Number
    3002807258
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Parmenide, 10/A
    City
    Carpi (MO) Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K080202

    Owner / Operator

    Firm Name
    IGEA S.p.A.
    Operator Number
    10025254
    Address
    Via Parmenide, 10/A
    City
    Carpi (MO)
    State
    Modena
    Postal Code
    41012
    Country
    IT
    Correspondent
    Chiara Guerrieri

    US Agent

    Business Name
    Orthofix US LLC
    Contact Name
    Amira Milutinovic
    Address
    3451 Plano Pkwy
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US
    Email
    [email protected]
    Phone
    214 9372196

    Products

    Device Name Product Code
    Low Energy Direct Current Thermal Ablation System OAB

    Proprietary Names

    6 Output Oncobionic Generator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)